Australia TGA ARTG record

Six Month Smile Patient Tray - Orthodontic appliance positioning tray, preloaded

Australia TGA ARTG Registered Device · Dr DJ Lee Pty Ltd · Xplora USA LLC dba Six Month Smiles · Class IIa · Started July 24, 2024

Good Name: Dr DJ Lee Pty Ltd - Six Month Smile Patient Tray - Orthodontic appliance positioning tray, preloaded

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: July 24, 2024
Effective Date: July 24, 2024

Sponsor

Name: Dr DJ Lee Pty Ltd

Manufacturer

Name: Xplora USA LLC dba Six Month Smiles
Country: United States of America
Address: 1501 Randolph Street Suite L6, Carrollton, Texas, 75006

Intended purpose

Patient matched set of devices required for orthodontic treatment.

About this record

Access comprehensive regulatory information for Six Month Smile Patient Tray - Orthodontic appliance positioning tray, preloaded in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Dr DJ Lee Pty Ltd, manufactured by Xplora USA LLC dba Six Month Smiles in United States of America. The device registration started on July 24, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.